Arterial hole closure apparatus

Abstract

An arterial closure device for use following coronary catherization procedures to close arterial access openings through the arterial wall while permitting post operative flow through the artery includes a housing having proximal and distal ends, and defining a longitudinal axis, first and second arterial tissue everting members mounted adjacent the distal end of the housing and first and second jaw members mounted adjacent the first and second tissue engaging members. The first and second arterial tissue everting members are dimensioned for at least partial positioning within the arterial access opening in the arterial wall and are deployable in at least a radial outward direction relative to the longitudinal axis of the housing to engage respective opposed arterial tissue portions on opposed sides of the opening and move the tissue arterial portions to an everted condition thereof. The first and second jaw members are adapted for relative movement between an open position to facilitate positioning about the arterial tissue portions in the everted condition and a closed position to at least partially draw the arterial tissue portions together to an at least partial approximated condition. An electrode is associated with at least one of the first and second jaw members and arranged to contact the respective arterial tissue portions. The electrode is adapted to be connected to a radio frequency energy source whereby energy is transmitted through the electrode to thermally fuse the arterial tissue positions between the first and second jaw members to substantially close the opening. Preferably, an electrode is associated with each of the first and second jaw members. Each electrode nay be configured as a bipolar electrode.

What is claimed is:  
     
       1. An apparatus for closing a vascular puncture, which comprises: 
       a housing having proximal and distal ends and defining a longitudinal axis;  
       at least two tissue engaging members disposed adjacent the distal end of the housing, the tissue engaging members deployable within the vascular puncture and cooperating to engage vascular tissue portions adjacent the vascular puncture, and being dimensioned and configured to arrange the vascular tissue portions to a desired orientation thereof; and  
       at least two outer jaw members positioned radially outwardly of the tissue engaging members and adapted for relative movement from an open position to facilitate positioning of the jaw members with respect to the vascular tissue portions when in the desired orientation, to a closed position to at least partially approximate the tissue portions, at least one of the jaw members having a thermal transmitting portion adapted to connect to an electrical energy source to transmit thermal energy to thermally fuse the approximated vascular tissue portions.  
     
     
       2. The apparatus according to  claim 1  wherein each jaw member includes a thermal transmitting portion adapted to connect to the electrical energy source. 
     
     
       3. An apparatus for closing a vascular puncture, which comprises: 
       a housing having proximal and distal ends;  
       at least two tissue engaging members disposed adjacent the distal end of the housing, the tissue engaging members deployable within the vascular puncture to engage vascular tissue portions adjacent the vascular puncture, and being dimensioned and configured to arrange the vascular tissue portions to a desired orientation thereof;  
       each tissue engaging member having a distal portion comprising a shape memory material adapted to assume a normal unstressed condition upon deployment to be in position to engage the vascular tissue portions to arrange the vascular tissue portions to the desired orientation; and  
       at least two jaw members mounted adjacent the tissue engaging members and adapted for relative movement from an open position to facilitate positioning of the jaw members with respect to the vascular tissue portions when in the desired orientation, to a closed position to at least partially approximate the tissue portions, at least one of the jaw members having a thermal transmitting portion adapted to connect to an electrical energy source to transmit thermal energy to thermally fuse the vascular tissue portions.  
     
     
       4. The apparatus according to  claim 3  wherein the distal portion defines a general J-shape. 
     
     
       5. The apparatus according to  claim 3  including an elongated shaft at least partially disposed in the housing. 
     
     
       6. The apparatus according to  claim 5  wherein the tissue engaging members are at least partially disposed within the elongated shaft, the tissue engaging members adapted for longitudinal movement relative to the elongated shaft between a first position wherein the distal portion of each tissue engaging member is in a stressed condition confined within the elongated shaft, and a second position wherein the distal portion of each tissue engaging member is exposed from the elongated shaft to assume the normal unstressed condition thereof. 
     
     
       7. The apparatus according to  claim 6  wherein the elongated shaft includes a longitudinal slot for accommodating the tissue engaging members. 
     
     
       8. The apparatus according to  claim 7  wherein the jaw members are adapted for longitudinal movement relative to the elongated shaft to move between the open and closed positions. 
     
     
       9. The apparatus according to  claim 8  wherein the elongated shaft includes camming structure which corresponds with corresponding camming structure of the jaw members to move the jaw members to the open position. 
     
     
       10. An apparatus for closing a vascular puncture, which comprises: 
       a housing having proximal and distal ends;  
       at least two tissue engaging members disposed adjacent the distal end of the housing, the tissue engaging members deployable within the vascular puncture to engage vascular tissue portions adjacent the vascular puncture, and being dimensioned and configured to arrange the vascular tissue portions to a desired orientation thereof;  
       at least two jaw members mounted adjacent the tissue engaging members and adapted for relative movement from an open position to facilitate positioning of the jaw members with respect to the vascular tissue portions when in the desired orientation, to a closed position to at least partially approximate the tissue portions, at least one of the jaw members having a thermal transmitting portion adapted to connect to an electrical energy source to transmit thermal energy to thermally fuse the vascular tissue portions; and  
       a thermal energy source connected to the thermal transmitting portion of the one jaw member.  
     
     
       11. The apparatus according to  claim 10  wherein the thermal energy source is a radio frequency energy source. 
     
     
       12. An apparatus for closing a vascular opening in a vascular wall, which comprises: 
       a housing having proximal and distal ends, and defining a longitudinal axis;  
       first and second tissue engaging members mounted adjacent the distal end of the housing, the first and second tissue engaging members being dimensioned for at least partially positioning within the vascular opening in the vascular wall, the first and second tissue engaging members being deployable from the housing to engage and expose internal vascular tissue portions adjacent the vascular opening and to arrange the vascular tissue portions at a predetermined orientation;  
       first and second jaw members mounted adjacent the first and second tissue engaging members, the first and second jaw members adapted for relative movement to engage the vascular tissue portions in the predetermined orientation and to substantially approximate the internal vascular tissue portions, at least one of the first and second jaw members having a thermal transmitting region, adapted for communication with a thermal energy source whereby thermal energy is transmitted through the thermal transmitting region to thermally fuse the approximated tissue portions between the first and second jaw members to substantially close the vascular opening;  
       a manually operable deployment member operatively connected to the first and second tissue engaging members, and being movable to deploy the first and second tissue engaging members; and  
       an actuator operatively connected to the first and second jaw members, the actuator movable to cause corresponding movement of the first and second jaw members.  
     
     
       13. An apparatus for closing a vascular opening in a vascular wall, which comprises: 
       a housing having proximal and distal ends, and defining a longitudinal axis;  
       first and second tissue engaging members mounted adjacent the distal end of the housing, the first and second tissue engaging members being dimensioned for at least partially positioning within the vascular opening in the vascular wall, the first and second tissue engaging members being deployable from the housing to engage and expose internal vascular tissue portions adjacent the vascular opening;  
       each tissue engaging member includes a distal memory portion comprising a shape memory material, the distal memory portion being adapted to assume a normal unstressed condition upon deployment to engage the vascular tissue portions;  
       first and second jaw members mounted adjacent the first and second tissue engaging members, the first and second jaw members adapted for relative movement to substantially approximate the internal vascular tissue portions subsequent to deployment of the first and second tissue engaging member, at least one of the first and second jaw members having a thermal transmitting region, adapted for communication with a thermal energy source whereby thermal energy is transmitted through the thermal transmitting region to thermally fuse the tissue portions between the first and second jaw members to substantially close the vascular opening;  
       a manually operable deployment member operatively connected to the first and second tissue engaging members, and being movable to deploy the first and second tissue engaging members; and  
       an actuator operatively connected to the first and second jaw members, the actuator movable to cause corresponding movement of the first and second jaw members.  
     
     
       14. The apparatus according to  claim 13  wherein an electrode is associated with each of the first and second jaw members. 
     
     
       15. The apparatus according to  claim 14  wherein each electrode is configured as a bipolar electrode. 
     
     
       16. The apparatus according to  claim 13  including an elongated shaft at least partially disposed in the housing. 
     
     
       17. The apparatus according to  claim 16  wherein the tissue engaging members are at least partially disposed within the elongated shaft, the tissue engaging members adapted for longitudinal movement relative to the elongated shaft between a first position wherein the distal memory portion of each tissue engaging member is in a stressed condition confined within the elongated shaft, and a second position wherein the distal memory portion of each tissue engaging member is exposed from the elongated shaft to assume the normal unstressed condition thereof. 
     
     
       18. A method of closing a vascular opening within a vascular organ, comprising the steps of: 
       introducing a vascular closure apparatus at least partially within a vascular opening in a vascular organ;  
       deploying tissue engaging members of the apparatus within the vascular organ;  
       engaging internal vascular tissue portions adjacent the vascular opening with the tissue engaging members;  
       approximating the internal vascular tissue portions; and  
       conducting electrical energy between the jaw members to at least partially fuse the internal vascular tissue portions.  
     
     
       19. The method according to  claim 18  wherein the tissue engaging members comprise a shape memory material, and wherein the step of deploying includes permitting the tissue engaging members to assume a normal unstressed condition so as to be in position to engage the internal vascular tissue portions to arrange the internal vascular tissue portions at a desired orientation. 
     
     
       20. The method according to  claim 19  wherein the step of approximating includes engaging the internal vascular tissue portions when in the desired orientation with jaw members of the apparatus and moving the jaw members to an approximated position. 
     
     
       21. The method according to  claim 20  wherein the step of conducting electrical energy comprises transmitting radio frequency energy from at least one of the jaw members. 
     
     
       22. An apparatus for closing an opening in tissue, which comprises: 
       an elongated shaft having proximal and distal ends, and defining a longitudinal axis;  
       first and second tissue engaging members at least partially disposed in the elongated shaft, each tissue engaging member having a distal engaging portion defining a normal unstressed arcuate condition, the tissue engaging members being adapted for longitudinal movement relative to the elongated shaft to be deployed within the opening in tissue whereby the distal engaging portions engage the tissue portions surrounding the opening to arrange the tissue portions at a desired orientation; and  
       first and second jaw members mounted about the elongated shaft and adapted for relative movement between an open position to receive the tissue portions and a closed position to approximate the tissue portions, at least one of the jaw members having a thermal transmitting portion adapted to connect to an electrical energy source to thermally fuse the tissue portions.  
     
     
       23. The apparatus according to  claim 22  wherein the elongated shaft includes camming surfaces to cooperate with camming surfaces of the jaw members to move the jaw members from the open to the closed positions thereof. 
     
     
       24. The apparatus according to  claim 22  wherein the jaw members are adapted for longitudinal movement relative to the elongated shaft to move between the open and closed positions thereof. 
     
     
       25. The apparatus according to  claim 22  wherein the first and second tissue engaging members are adapted for longitudinal movement between a first position wherein the distal engaging portions are at least partially disposed in a stressed condition within the elongated shaft and a second position wherein the distal engaging portions are deployed to assume the normal unstressed arcuate condition thereof.